CurrentCentenePolicy CP.PHAR.179

Romiplostim (Nplate) (PDF)

Defines medical necessity criteria, approval durations, dosing limits, and prior authorization requirements for romiplostim (Nplate) across indications including ITP, HS-ARS, and NCCN-recommended off-label uses (MDS, CIT, immune checkpoint inhibitor-related toxicities) for Centene lines of business (Commercial, HIM, Medicaid).

Policy Summary

PayerCentene

PolicyRomiplostim (Nplate) (PDF)

Policy CodePolicy CP.PHAR.179

Change TypeMultiple updates (codes added/removed, approval duration and criteria revisions, step therapy additions/removals, exclusions)

Effective DateMar 1, 2016

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

HCPCS code J2802 added and J2796 deleted.

For ITP and NCCN supported uses, initial approval duration revised from 6 to 12 months.

Added redirection to eltrombopag (generic Promacta) for ITP and MDS as a step therapy requirement.

Added NCCN Compendium supported off-label use for immune checkpoint inhibitor-related toxicities when member has had no response to corticosteroids after 1-2 weeks.

Added exclusion of concurrent use with spleen tyrosine kinase inhibitor (e.g., Tavalisse™).

For CIT added requirement for age at least 18 years per NCCN guidelines.

1Q 2025 annual review: no significant changes; references reviewed and updated.

3FDA-approved indications (ITP adult, ITP pediatric ≥1 yr, HS-ARS)

3NCCN off-label supported uses listed (MDS, CIT, ICI-related toxicities)

10 mcg/kgMaximum recommended dose (weekly)

J2802Current HCPCS product code

Coverage Summary & Scope

Scope: Defines medical necessity criteria, approval durations, dosing limits, and prior authorization requirements for romiplostim (Nplate) across Centene lines of business: Commercial, HIM, Medicaid. Coverage stance: covered_with_criteria.

Indications covered: FDA‑approved for immune thrombocytopenia (ITP) in adults and pediatric patients ≥1 year and for hematopoietic syndrome of acute radiation syndrome (HS‑ARS). Policy also incorporates NCCN‑recommended off‑label uses including myelodysplastic syndromes (MDS), chemotherapy‑induced thrombocytopenia (CIT), and immune checkpoint inhibitor‑related toxicities (ICI‑related toxicities).

Lines‑of‑business applicability: Commercial, HIM, Medicaid. Approval durations summary: default initial and re‑authorization approvals for ITP and NCCN supported off‑label uses are 12 months where specified; HS‑ARS approval is a single dose with duration 4 weeks (1 dose only) and is not eligible for re‑authorization.

Key thresholds and policy info

ITP initial platelet thresholdCurrent (within the last 30 days) platelet count < 30,000/µL or member has an active bleed

ITP continuation thresholdCurrent (within the last 90 days) platelet count < 400,000/µL

CIT platelet thresholdPlatelets < 100,000/µL for ≥ 3 weeks following the last chemotherapy administration

HS-ARS radiation exposure thresholdSuspected or confirmed exposure to radiation levels greater than 2 gray (Gy)

Maximum dose10 mcg/kg per week (ITP); single HS-ARS dose limited to 10 mcg/kg

Current HCPCS product codeJ2802

Policy statusCURRENT

Last review02.26

Initial Therapy Criteria

A. Hematopoietic Syndrome of Acute Radiation Syndrome (HS-ARS)

must meet all

ALL of the following

Diagnosis of HS-ARS
Prescriber attestation that there has been suspected or confirmed exposure to radiation levels greater than 2 gray (Gy)
Prescribed by or in consultation with a hematologist
Dose does not exceed 10 mcg/kg
Single HS-ARS dose limited to 10 mcg/kg

B. Immune Thrombocytopenia (ITP) - Initial authorization

Continuation / Re-authorization Criteria

B. Immune Thrombocytopenia (ITP) - Re-authorization / Continued therapy

must meet all

ALL of the following

ANY of the following
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums CC.PHARM.03A and CC.PHARM.03B)
Member is responding positively to therapy (e.g., increase in platelet count from baseline, reduction in bleeding events)

Exclusions and Not-Recommended Uses

Concurrent‑use exclusions: romiplostim must not be prescribed concurrently with rituximab and must not be prescribed concurrently with another thrombopoietin receptor agonist (examples listed: Promacta® [eltrombopag], Doptelet®, Mulpleta®), per ITP and NCCN off‑label criteria.

Added exclusion (1Q2024): policy explicitly excludes concurrent use with spleen tyrosine kinase inhibitors (e.g., Tavalisse™).

Routing for unlisted uses: requests for uses not specifically listed in the policy are directed to the applicable off‑label use policy for the line of business (e.g., CP.CPA.09; HIM.PA.154; CP.PMN.53).

Applicable Codes

HCPCS - Romiplostim product codeHCPCS

J2802

Injection, romiplostim, 1 microgram

Provider Requirements & Billing Rules

Prior Authorization

Prescriber specialty requirement

Prescriptions must be written by or in consultation with a hematologist for ITP and HS-ARS; for NCCN-recommended off-label uses (e.g., MDS, CIT, immune checkpoint inhibitor–related toxicities) prescriptions must be by or in consultation with an oncologist or hematologist.

Illinois HIM exception: per IL HB 5395 (effective 1/1/2026) certain step therapy requirements do not apply to Illinois HIM requests (see policy notes).

Documentation Required

Submit supporting documentation

Include office chart notes, recent laboratory results, and any other clinical information demonstrating the member meets the approval criteria.

Examples: office visit notes documenting diagnosis and prior therapy (e.g., corticosteroid use), platelet lab results (dates and values), documentation of prior eltrombopag use or contraindication, and evidence of response for continuation requests.

Clinical Evidence & Guidance

Evidence: Primary source cited is the Nplate Prescribing Information (Amgen), March 2025.

Guideline support: policy references NCCN compendia (MDS, Hematopoietic Growth Factors, ICI toxicity guidance) and ASH ITP guidelines as supporting guidance for indications and off‑label recommendations.

NCCN support and prescriber requirements: NCCN‑supported off‑label uses include MDS, CIT, and ICI‑related toxicities. For off‑label dosing or regimens, the prescriber must submit supporting evidence (practice guidelines or peer‑reviewed literature) to justify doses that exceed standard limits or are non‑FDA regimens.

Background

Background: Romiplostim is a thrombopoietin receptor agonist used to stimulate platelet production. FDA‑approved indications include treatment of thrombocytopenia in adults and pediatric patients ≥1 year with immune thrombocytopenia (ITP) and to increase survival after acute myelosuppressive radiation exposure (HS‑ARS).

Dosing and limits: typical ITP initial dosing starts at 1 mcg/kg SC weekly with titration; maximum recommended dose is 10 mcg/kg per week. For HS‑ARS a single SC dose of 10 mcg/kg is specified and should be given as soon as possible after suspected/confirmed exposure > 2 gray (Gy).

Policy updates: recent policy expansions incorporated NCCN off‑label uses (MDS, CIT) and added inclusion of immune checkpoint inhibitor‑related toxicities per NCCN compendium guidance. Definitions/glossary entries included: HS‑ARS (Hematopoietic Syndrome of Acute Radiation Syndrome), CIT (chemotherapy‑induced thrombocytopenia), and IPSS‑R (Revised International Prognostic Scoring System for MDS).

Revision History

11.12.24coding change

HCPCS code J2802 added and J2796 deleted.

11.14.24administrative review

1Q 2025 annual review: no significant changes; references reviewed and updated.

10.22.25policy revision

Added NCCN Compendium–supported off-label use for immune checkpoint inhibitor–related toxicities when member has had no response to corticosteroids after 1–2 weeks (1Q2026 review; P&T approval 02.26).

Policy Summary

PayerCentene

PolicyRomiplostim (Nplate) (PDF)

Policy CodePolicy CP.PHAR.179

Change TypeMultiple updates (codes added/removed, approval duration and criteria revisions, step therapy additions/removals, exclusions)

Effective DateMar 1, 2016

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

SourceLink

On This Page

ALL of the following

Diagnosis of ITP
Prescribed by or in consultation with a hematologist
Age ≥ 1 year
one of
- Current (within the last 30 days) platelet count is < 30,000/µL
- Member has an active bleed
Failure of a systemic corticosteroid, unless contraindicated or clinically significant adverse effects are experienced
See Appendix B
Failure of eltrombopag (generic Promacta®), unless contraindicated or clinically significant adverse effects are experienced
Per IL HIM requests step therapy requirements do not apply as of 1/1/2026 (IL HB 5395)
Nplate is not prescribed concurrently with rituximab or another thrombopoietin receptor agonist (e.g., Promacta®, Doptelet®, Mulpleta®) or spleen tyrosine kinase inhibitor (e.g., Tavalisse™)
Dose does not exceed 10 mcg/kg per week
Dose ceiling: 10 mcg/kg per week

C. Recommended NCCN uses (off-label) - Initial authorization

must meet all

ALL of the following

diagnosis is one of
- Myelodysplastic syndromes (MDS)
- Chemotherapy-induced thrombocytopenia (CIT)
- Immune checkpoint inhibitor-related toxicities
Prescribed by or in consultation with an oncologist or hematologist
for MDS must meet all
- Lower-risk MDS (i.e., IPSS-R [Very Low, Low, Intermediate])
- Severe or refractory thrombocytopenia following disease progression or no response to hypomethylating agents (e.g., azacitadine, decitabine), immunosuppressive therapy (e.g., Atgam®, cyclosporine), or clinical trial
- Failure of eltrombopag (generic Promacta), unless contraindicated or clinically significant adverse effects are experienced
for CIT must meet both
- Age ≥ 18 years
- Member has platelets < 100,000/µL for ≥ 3 weeks following the last chemotherapy administration and/or following delays in chemotherapy initiation related to thrombocytopenia
For immune checkpoint inhibitor-related toxicities, member has had no response to corticosteroids after 1-2 weeks
Nplate is not prescribed concurrently with rituximab or another thrombopoietin receptor agonist (e.g., Promacta®, Doptelet®, Mulpleta®)
dose requirement (one of)
- Dose does not exceed 10 mcg/kg per week
  Dose ceiling: 10 mcg/kg per week
- Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
Prescribed regimen must be FDA-approved or recommended by NCCN

D. Other diagnoses/indications

must meet one of

ANY of the following

If drug has recently (within the last 6 months) undergone a label change not yet reflected in this policy, refer to formulary/no coverage or non-formulary policies listed (CP.CPA.190; HIM.PA.33; CP.PMN.255; HIM.PA.103; CP.PMN.16)
If requested use is NOT specifically listed under 'Diagnoses/Indications for which coverage is NOT authorized' AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09; HIM.PA.154; CP.PMN.53)

Current (within the last 90 days) platelet count is < 400,000/µL

Nplate is not prescribed concurrently with rituximab or another thrombopoietin receptor agonist (e.g., Promacta, Doptelet, Mulpleta) or spleen tyrosine kinase inhibitor (e.g., Tavalisse™)

If request is for a dose increase, new dose does not exceed 10 mcg/kg per week

Dose ceiling for increases: 10 mcg/kg per week

Step Therapy

Step therapy requirement (eltrombopag)

Failure of eltrombopag (generic Promacta®) is required prior to approval unless it is contraindicated or causes clinically significant adverse effects.

Illinois HB 5395 exception: for Illinois HIM requests, step therapy requirements (including eltrombopag redirection) do not apply as of 1/1/2026.

Documentation Required

Response documentation for continuation

For re-authorization, provide documentation showing the member is responding to therapy: increase in platelet count from baseline, reduction in bleeding events, and recent platelet laboratory results within required timeframes.

Required evidence: platelet count trends (current within last 90 days for continuation), clinical notes describing bleeding improvement or reduced transfusion/bleeding events, and any other relevant labs or clinician assessments.

Billing Rule

Dose ceiling enforcement

Requests for doses that exceed 10 mcg/kg per week will not meet criteria; for HS-ARS the single permitted dose is limited to 10 mcg/kg.

Affected code: J2802 (Injection, romiplostim, 1 microgram)
HS-ARS single-dose limit: 10 mcg/kg

09.23.25policy revision

Revised initial approval duration for ITP and NCCN-supported uses from 6 months to 12 months; per August/September SDC added redirection to eltrombopag (generic Promacta) for ITP and MDS and removed prior redirection to immune globulin for certain ITP scenarios (P&T approval 12.25).

02.24policy revision

1Q 2024 annual review: added exclusion of concurrent use with a spleen tyrosine kinase inhibitor (e.g., Tavalisse™).

02.23policy revision

1Q 2023 annual review: for chemotherapy‑induced thrombocytopenia (CIT) added requirement that age is ≥ 18 years per NCCN guidance; added concurrent‑use exclusions with other thrombopoietin receptor agonists for off‑label uses.